2-day In-person Seminar on Regulatory Compliance for Dietary Supplements in the US, EU and Canada at Boston

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2-day In-person Seminar on Regulatory Compliance for Dietary Supplements in the US, EU and Canada at Boston Powered By Docstoc
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    2-day In-person Seminar on
     Regulatory Compliance for Dietary Supplements in the US, EU and
     Canada

                                                                                                                                 
     Course "Regulatory Compliance for Dietary Supplements in the
     US, EU and Canada " has been pre-approved by RAPS as
                                                                                            Register Now                         
     eligible for up to 12 credits towards a participant's RAC
     recertification upon full completion.


    Date & Time:                                                                      Instructor Profile:

     September 13th and 14th 2012         8 AM to 5 PM EDT
                                                                                                  James E. Russell
     Duration: 2 Days                     Instructor: James E. Russell                          Director of Regulatory
                                                                                              Affairs, RJR Consulting Inc
                                          Price : $1495.00   (for one
     Location: Boston
                                          participant)
                                                                                      Mr. Russell is the Director of
             Register for 4 Participants to Get 1 Free Pass                           Regulatory Affairs and Business
                                                                                      Development for RJR Consulting Inc,
                                                                                      a leading global regulatory
                                                                                      consulting firm servicing the Life
    Overview:
                                                                                      Science and Consumer Products
    A growing public demand for supplements has resulted in a flurry of               industries. Mr. Russell has 13 years
    companies creating and marketing dietary supplements in the United                of experience in the Life Science
    States, EU and Canada. With the regulatory authorities beginning to               field, encompassing foods, dietary
    take a stronger stance on enforcement of regulatory policies,                     supplements, medical devices and
                                                                                      pharmaceuticals. James joined RJR
    procedures and GMP compliance, it is important for companies to
                                                                                      Consulting in 2009 to assist
    verify that their products comply with the latest regulations and
                                                                                      companies with their global
    provisions if they plan to market Supplements in these countries.                 regulatory, manufacturing and
                                                                                      distribution needs.
    This 2-day interactive live seminar will review the regulations that
    impact Dietary Supplements in the US, EU and Canada and discuss                   Prior to RJR, Mr. Russell worked for
    how to verify that products are compliant with these regulations.                 a large life science distribution
    Differences with food and drug regulation in these countries will be              company with organizational
                                                                                      responsibilities including regulatory,
    noted as well. We will also cover what qualifies as a dietary
                                                                                      supply chain, business strategy and
    supplement or dietary ingredient, how to ensure GMP compliance as
                                                                                      product data quality. Mr. Russell
    well as detailed requirements for labeling and acceptable marketing               currently teaches on a variety of
    claims. An update on current events within the Supplement industry                regulatory topics and is a
    and the potential impacts to Manufacturers and Distributors in the                participating member of the
    US, EU and Canada will also be presented and discussed.                           Regulatory Affairs Professionals
                                                                                      Society (RAPS). ...more

    Course Outline:

                                                                                     Suggest a Topic        More Webinars
    Course Outline: Day 1:
                                                                                       Your Necessity is our Priority
    Dietary Supplement Regulation in the U.S.


    Lecture 1: Dietary Supplement Overview


       l   What is a dietary supplement?                                                                 
       l   Supplements vs.
              ¡   Pharmaceuticals
              ¡   OTC Drugs
              ¡   Conventional Foods
              ¡   Medical foods
              ¡   Natural products
              ¡   Herbal medicinal products


    Lecture 2: Organizations and Regulatory Structure


       l   FDA Structure regarding Dietary Supplements
       l   Industry Groups


    Lecture 3: History of Dietary Supplement Regulation


       l   Early History
       l   DSHEA
       l   Code of Federal Regulations


    Lecture 4: Manufacturing Considerations
   l   Company & Facility Registration
   l   GMP Requirements
   l   GMP inspections


Lecture 5: Dietary Ingredients


   l   What qualifies as a dietary ingredient?
   l   Old dietary ingredients vs. New dietary ingredients
   l   New Dietary Ingredient Notification (NDIN)
   l   Updated New Dietary Ingredient Guidance from FDA


Lecture 6: Labeling Considerations


   l   Display Panels & Layout
   l   Supplement Facts Panel
   l   Labeling Claims
           ¡   Health claims
           ¡   Disease Claims
           ¡   Structure/Function claims
           ¡ Disclaimers/Substantiation
   l   Notification of labeling claims to FDA
   l   Dietary Supplement Labeling Act


Lecture 7: Advertising Considerations


   l   FDA vs. FTC jurisdiction
   l   Enforcement
   l   Expressed vs. Implied Claims
           ¡ Exercises & examples
   l   Disclosures                                            
   l   Claim Substantiation
   l   Testimonials


Course Outline: Day 2:


Food Supplement regulation in the EU

Lecture 8: Overview


   l   What is a food supplement?
   l   Borderline products
   l   Medicinal Foods


Lecture 9: Organizations and Regulatory Structure


   l   EU Regulatory Structure
   l   Industry Groups


Lecture 10: Supplement Regulation


   l   Early History
   l   Food Supplement Directive


Lecture 11: Manufacturing Considerations


   l   Company & Facility Registration
   l   GMP Requirements


Lecture 12: Dietary Ingredients


   l   What qualifies as a dietary ingredient?
   l   Ingredient safety
   l   RDA vs RDI
   l   DRV vs % Daily Value


Lecture 13: Labeling Considerations


   l   Display Panels & Layout
   l   Labeling Claims
          ¡ Health claims
          ¡ Disease Claims
          ¡ Reduction of Disease Risk Claims

           ¡ Nutrition Claims
   l   Notification requirements


Lecture 14: Advertising Considerations


   l   Enforcement
   l   Claim Substantiation
 Natural Health Product regulation in Canada

 Lecture 15: Overview


     l   What is a Natural Health Product?


 Lecture 16: Organizations and Regulatory Structure


     l   Canadian Regulatory Structure
            ¡   Health Canada
            ¡   Canadian Health Products Directorate


 Lecture 17: Supplement Regulation


     l   National Health Products Regulation
     l   Differences between Canada and US
     l   Supplements monographs
     l   Requirements for pre-market approval


 Lecture 18: Manufacturing Requirements for Natural Health
 Products in Canada

 Lecture 19: Dietary Ingredients


 Lecture 20: Labeling Considerations

 Lecture 21: Advertising Considerations

 Lecture 22: Enforcement and Post-Marketing Surveillance


 Click here to register for this seminar


  Who Will Benefit:


     l   Executives/Managers within Dietary Supplement or Natural
         Product companies
     l   Regulatory Compliance Professionals in the Supplements or
         Natural Products area
     l   Quality Assurance or Quality Control Professionals
     l   Dietary Supplement or Natural Product Manufacturers &
         Distributors
     l   Sales/Marketing Personnel in the Supplement or Natural
         Product Industries



It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel



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DOCUMENT INFO
Description: A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries.